Disease

Regulatory Science

BioCardia wins FDA backing for single-trial PMA path for CardiAMP

FDA confirmed that BioCardia's ongoing CardiAMP HF II trial may alone support a Premarket Approval application for its autologous cell therapy in ischaemic HFrEF.
FDA confirmed that BioCardia's ongoing CardiAMP HF II trial may alone support a Premarket Approval application for its autologous cell therapy in ischaemic HFrEF.
The Biotech Times Editorial Team  · 

Fractyl Health: Revita holds 78% of GLP-1 weight loss at one year

One-year REVEAL-1 open-label data show a single endoscopic Revita procedure sustains most GLP-1-induced weight loss after drug discontinuation.
One-year REVEAL-1 open-label data show a single endoscopic Revita procedure sustains most GLP-1-induced weight loss after drug discontinuation.
The Biotech Times Editorial Team  · 
Biotech

Hengrui and Kailera report ribupatide Phase 2 oral data at ADA 2026

Oral ribupatide delivered up to 12.1% mean weight loss at 26 weeks in a China Phase 2 trial, with no observed plateau and a
Oral ribupatide delivered up to 12.1% mean weight loss at 26 weeks in a China Phase 2 trial, with no observed plateau and a
The Biotech Times Editorial Team  · 
Regulatory Science

Memo Therapeutics presents Phase II data on potravitug for BKPyV

Propensity-score-matched analysis showed potravitug nearly doubled viral clearance rates vs controls in kidney transplant recipients with BK polyomavirus infection.
Propensity-score-matched analysis showed potravitug nearly doubled viral clearance rates vs controls in kidney transplant recipients with BK polyomavirus infection.
The Biotech Times Editorial Team  · 
Biotech

Zealand Pharma petrelintide hits 10.7% weight loss at 42 weeks

Phase 2 ZUPREME-1 data show the amylin analogue achieved double-digit weight reduction with near-placebo tolerability, ahead of planned Phase 3 initiation.
Phase 2 ZUPREME-1 data show the amylin analogue achieved double-digit weight reduction with near-placebo tolerability, ahead of planned Phase 3 initiation.
The Biotech Times Editorial Team  · 
Regulatory Science

InnoCare orelabrutinib hits Phase IIb endpoints in SLE study

Orelabrutinib met primary and secondary endpoints in a 187-patient Phase IIb SLE trial, with 57% SRI-4 response versus 34% for placebo at week
Orelabrutinib met primary and secondary endpoints in a 187-patient Phase IIb SLE trial, with 57% SRI-4 response versus 34% for placebo at week
The Biotech Times Editorial Team  · 
Diagnostics
Biotech

ACTG launches Phase 2 trial of dasatinib to shrink HIV reservoir

The global trials network has opened study A5413, testing whether the repurposed cancer drug dasatinib can reduce latent HIV by blocking CD4 cell proliferation.
The global trials network has opened study A5413, testing whether the repurposed cancer drug dasatinib can reduce latent HIV by blocking CD4 cell proliferation.
The Biotech Times Editorial Team  · 
Regulatory Science

Attralus wins FDA orphan drug status for AL amyloidosis candidate AT-02

Zamubafusp alfa now holds four orphan designations globally as Attralus advances the pan-amyloid removal antibody through a Phase 2 trial.
Zamubafusp alfa now holds four orphan designations globally as Attralus advances the pan-amyloid removal antibody through a Phase 2 trial.
The Biotech Times Editorial Team  · 
Genomics

Biogen's salanersen wins FDA Breakthrough Therapy tag for SMA

The designation is backed by Phase 1b data showing motor function gains in children who had a suboptimal response to prior gene therapy.
The designation is backed by Phase 1b data showing motor function gains in children who had a suboptimal response to prior gene therapy.
The Biotech Times Editorial Team  · 
Pharmaceuticals
Regulatory Science

GH Research publishes Phase 2a PPD data for inhaled GH001

All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.
All ten patients in GH Research's open-label trial achieved remission within two hours of a single inhaled dose of mebufotenin, the company reports.
The Biotech Times Editorial Team  · 
Regulatory Science

Gilead and Lakefront close Ouro Medicines deal for $1.675bn

The acquisition adds gamgertamig, a BCMAxCD3 T cell engager, to Gilead's inflammation portfolio; registrational studies are expected as early as 2027.
The acquisition adds gamgertamig, a BCMAxCD3 T cell engager, to Gilead's inflammation portfolio; registrational studies are expected as early as 2027.
The Biotech Times Editorial Team  · 
Regulatory Science

Novartis ALIGN data show Vanrafia slows IgAN kidney decline by 34%

Final 2.5-year Phase III results, published in The Lancet, back a traditional approval filing for atrasentan in IgA nephropathy later this year.
Final 2.5-year Phase III results, published in The Lancet, back a traditional approval filing for atrasentan in IgA nephropathy later this year.
The Biotech Times Editorial Team  · 
Diagnostics

Spectral Medical PMX shows sustained mortality benefit at 12 months

Tigris Phase 3 data show PMX reduced 12-month mortality to 52.8% versus 66.7% for standard care, with a 95.9% Bayesian probability
Tigris Phase 3 data show PMX reduced 12-month mortality to 52.8% versus 66.7% for standard care, with a 95.9% Bayesian probability
The Biotech Times Editorial Team  · 
Regulatory Science

Abivax Phase 3 data show obefazimod hits all UC endpoints

Both doses of Abivax's oral miR-124 enhancer achieved placebo-adjusted remission rates above 39% at 44 weeks, with an NDA filing planned for
Both doses of Abivax's oral miR-124 enhancer achieved placebo-adjusted remission rates above 39% at 44 weeks, with an NDA filing planned for
The Biotech Times Editorial Team  · 
Biotech

JJP Biologics: nebaprubart shows early efficacy in rare LAD trial

Interim Phase 1b data show rapid blister reduction and dapsone tapering in Linear IgA Disease, supporting a rheumatoid arthritis trial in Q3 2026.
Interim Phase 1b data show rapid blister reduction and dapsone tapering in Linear IgA Disease, supporting a rheumatoid arthritis trial in Q3 2026.
The Biotech Times Editorial Team  · 
Regulatory Science

J&J nipocalimab meets Phasea 2 primary endpoint in lupus study

Phase 2 JASMINE data show nipocalimab reduced SLE disease activity through 52 weeks, with stronger responses in autoantibody-positive patients.
Phase 2 JASMINE data show nipocalimab reduced SLE disease activity through 52 weeks, with stronger responses in autoantibody-positive patients.
The Biotech Times Editorial Team  · 
Genomics

Ziftomenib triplet shows 87% ORR in venetoclax-naive R/R AML

Blood publication of KOMET-007 data shows deep, durable responses for ziftomenib plus venetoclax/azacitidine in NPM1-mutated relapsed/refractory AML.
Blood publication of KOMET-007 data shows deep, durable responses for ziftomenib plus venetoclax/azacitidine in NPM1-mutated relapsed/refractory AML.
The Biotech Times Editorial Team  · 
Cell & Gene Therapy
Biotech

Legend Biotech reports 100% ORR in Phase 1 in vivo CAR-T NHL trial

LB2501, a single-infusion in vivo CAR-T candidate, achieved 100% objective response in six relapsed/refractory NHL patients with no dose-limiting toxicities.
LB2501, a single-infusion in vivo CAR-T candidate, achieved 100% objective response in six relapsed/refractory NHL patients with no dose-limiting toxicities.
The Biotech Times Editorial Team  · 
Regulatory Science

Vera Therapeutics aligns with FDA on earlier atacicept Phase 3 eGFR read

Vera Therapeutics has pulled forward its ORIGIN 3 eGFR analysis to Q3 2026, opening a path to full IgAN approval as early as 2027.
Vera Therapeutics has pulled forward its ORIGIN 3 eGFR analysis to Q3 2026, opening a path to full IgAN approval as early as 2027.
The Biotech Times Editorial Team  · 
Subscribe to Disease